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Safety and Early Effectiveness of Intramyocardial Cardiac Atrial Stem Cells Compared with Sodium Chloride in Patients with Advanced Ischemic Heart Failure

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on patients with advanced Heart Failure caused by previous heart attacks that have left the left side of the heart weak. The experimental treatment consists of an injection of cardiac atrial stem cells, which are cells taken from the atrial tissue of donor hearts and delivered directly into the heart muscle. For comparison, a simple saline solution (placebo) is used.

The purpose of the study is to evaluate the safety of the cell therapy when given during a surgical procedure. Participants undergo a routine heart operation during which the intramyocardial injection is performed, followed by a period of monitoring in the hospital and scheduled clinic visits over several months to watch for any serious problems such as death, need for readmission, Myocardial infarction or tumor growth.

Safety assessments include tracking any worsening of heart symptoms, sudden cardiac events that require emergency treatment, and changes in functional ability measured by a six‑minute walk test. Heart function is also examined using imaging to see how well the left ventricle pumps and whether the size of the damaged area changes. Improvement in symptoms is recorded by changes in NYHA class, a standard way of describing how breathless a person feels during normal activities.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Evaluation

    After joining the study, you will undergo a series of examinations to document your current heart condition and overall health. These assessments may include medical history review, physical examination, and heart imaging. The information collected will serve as a reference for later comparisons.

    The purpose of this evaluation is to confirm that you meet the study criteria for advanced ischemic heart failure and to establish baseline values for safety and effectiveness measurements.

  2. Step 2

    Surgical Procedure and Intramyocardial Injection

    You will be taken to the operating room where a heart surgeon will perform a minimally invasive procedure. During the operation, a suspension of cardiac atrial stem cells will be injected directly into the heart muscle (intramyocardial injection).

    If you are assigned to the control group, the surgeon will inject a saline solution known as placebo (0.9 % sodium chloride) instead of stem cells. No specific dosage amount is provided in the study protocol.

  3. Step 3

    Immediate Post‑Operative Monitoring

    Following the injection, you will remain in the hospital for close observation. Medical staff will monitor you for any signs of major adverse cardiac events (MACE), which include death, heart attack, re‑admission to the hospital, and tumor formation.

    Additional safety checks will look for worsening heart‑failure symptoms, sudden‑death events, and any urgent need for treatment.

  4. Step 4

    Discharge and Home Recovery

    If the post‑operative monitoring shows no immediate complications, you will be discharged to continue recovery at home. Instructions will be given on activity level, medication use, and signs that require urgent medical attention.

  5. Step 5

    Follow‑up Visits

    Throughout the study period, you will attend scheduled follow‑up visits. During these visits, the research team will evaluate safety by checking for non‑MACE events such as worsening heart failure, sudden‑death episodes, and the need for unscheduled treatment.

    Effectiveness will be assessed with tests such as the Six‑Minute Walk Test, evaluation of NYHA class (a classification of heart‑failure severity), heart‑function imaging, ventricular dimension measurements, and assessment of infarct size.

    These visits will continue until the study ends, allowing the investigators to determine the overall safety and preliminary effectiveness of the treatment.

Who can join the trial?

11 criteria

  • Must be a male or female who is older than 18 years.
  • Must have had a documented myocardial infarction (heart attack) caused by blockages in the heart arteries (coronary artery atherosclerotic disease) that was shown on an ECG (electrocardiogram) test.
  • Must have an area of the heart that does not move normally (called hypokinetic, akinetic or dyskinetic) as seen on an ultrasound of the heart (echocardiography), an X‑ray video of the heart (ventriculography) or an MRI scan.
  • Must show scar tissue in that heart area on an MRI scan using a special dye (gadolinium delayed enhancement) that highlights scar tissue.
  • Must have a left‑ventricle pumping ability (left ventricular ejection fraction) between 25 % and 45 % as measured by standard heart imaging tests.
  • Must need heart‑bypass surgery (CABG) to restore blood flow to the damaged area, or a cardiologist must confirm that no other re‑vascularization procedure is required.
  • Must have safety laboratory test results and pre‑surgery blood tests that are judged acceptable for surgery.
  • Women who could become pregnant (including peri‑menopausal women who have had a period in the last year) must have a negative pregnancy test before entering the study.
  • Women who could become pregnant must use a reliable birth‑control method that fails less than 1 % per year, starting at least two months before the trial and continuing throughout the study.
  • Must understand the study, agree to follow all procedures, and sign the informed consent form.
  • Must be able to give consent and follow the study schedule, and be mentally, emotional and physically able to comply with postoperative care and follow‑up visits.

Who cannot join the trial?

21 criteria

  • You have a non‑heart disease that doctors expect will shorten your life to less than one year.
  • You have NYHA class IV congestive heart failure, which means very severe heart failure with symptoms even while at rest.
  • A screening exam of your chest, abdomen, or pelvis shows a tumour (an abnormal growth of cells).
  • You are currently on a transplant waiting list or have ever received a solid organ transplant (such as a kidney or liver).
  • You are pregnant or are feeding a baby directly from your breast.
  • You are involved in, or plan to start, a lawsuit about health problems.
  • You are a prisoner (incarcerated).
  • You have previously received any kind of cellular therapy (treatment using living cells).
  • You have been treated for a malignancy (cancer) or a pre‑cancer condition and have not been confirmed disease‑free for at least five years.
  • You have a chronic kidney (renal) or liver (hepatic) disease, or any other serious long‑term illness, that could make the surgery dangerous for your survival.
  • You have any other illness that could lower your expected remaining lifespan to less than two years from the time of screening.
  • You have any contraindications to MRI (magnetic resonance imaging), such as a non‑compatible implanted device (e.g., certain pacemakers or defibrillators), an estimated glomerular filtration rate below 50 ml/min (a measure of kidney function), a known allergic reaction to the contrast agent gadolinium, severe claustrophobia, or the presence of metal objects like certain shunts, prostheses, bullets, or tattoos that might interfere with the scan.
  • You are taking long‑term immunosuppressive medication (drugs that weaken the immune system) for an inflammatory or systemic disease.
  • You have a history of an autoimmune disease (where the body attacks itself) such as systemic lupus erythematosus, Addison’s disease, active Crohn’s disease, or rheumatoid arthritis.
  • You have a history of a cardiac tumour (a tumor in the heart) or one was seen on an MRI scan.
  • It is not technically possible to restore blood flow to the artery that caused your heart attack (revascularisation is not feasible).
  • You currently have problems with alcohol or drug abuse that could make it hard to follow the study procedures.
  • Your liver blood test (GPT) is more than three times the normal upper limit, or your blood counts are abnormal (hematocrit below 25 %, white blood cells below 3,000, or platelets below 100,000) without a reversible cause.
  • You have severely reduced kidney function, shown by a serum creatinine level higher than 3.0 mg/dL, or you are currently on dialysis (a treatment that filters waste from the blood).
  • You have experienced ventricular tachycardia or ventricular fibrillation (dangerous rapid heart rhythms) that are not linked to an acute heart‑blood‑flow problem.
  • You have symptoms from a dangerous heart rhythm (ventricular tachyarrhythmia) that occurred during your recent heart attack.
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Investigated drugs

Cardiac atrial stem cells are stem cells taken from the atrial tissue of a donor heart. In this trial they are delivered directly into the heart muscle of patients with severe heart failure caused by reduced blood flow and previous heart attacks. The cells are injected during surgery with the goal of helping the damaged heart tissue repair itself and improve heart function. The study mainly looks at whether this direct injection is safe, checking for serious heart problems, deaths, re‑hospitalizations, new heart attacks, or any signs of tumor growth.

What is already known about the treatment

  • NaCl 0.9 % B. Braun, solution for infusion

    This sterile saline is given by direct injection into the heart muscle (intracardiac infusion) as a control fluid during the trial. It is a well‑known electrolyte solution that has been used for many decades in hospitals worldwide. The solution helps maintain fluid balance by providing sodium and chloride ions, but it does not treat disease. It is classified as an electrolyte solution (ATC code B05BB01).

  • Cardiac atrial stem cells

    The stem cell product is delivered as a cell suspension that is injected straight into the heart muscle (intramyocardial injection). It is an experimental therapy currently being studied in early‑phase clinical trials for patients with advanced ischemic heart failure. The cells are intended to repair damaged heart tissue by turning into heart‑like cells and releasing factors that promote healing and new blood‑vessel growth. This treatment falls under the category of cell‑based stem cell therapy.

Investigated diseases

Heart Failure - Heart Failure is a condition in which the heart’s ability to pump blood is reduced, leading to inadequate blood flow to meet the body’s needs. Over time the heart muscle may become stretched or thickened, and fluid can accumulate in the lungs and other tissues. Patients often experience increasing shortness of breath, fatigue, and swelling in the legs as the condition progresses. The severity can change from mild symptoms during activity to more persistent problems at rest.
Trial detailsLast updated 14 Nov 2026
Age18+ yearsPhasePhase I/IITrial ID2024-517031-51-01Estimated enrolment20 patientsSponsorCASC8

sourced from the EU Clinical Trials Register and site verification

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